DISCUS

• Research type

  Research Study

• Full title

  Duroplasty for Injured cervical Spinal Cord with Uncontrolled Swelling

• IRAS ID

  292031

• Contact name

  Marios Papadopoulos

• Contact email

  mpapadop@sgul.ac.uk

• Sponsor organisation

  St George's University of London (SGUL)

• ISRCTN Number

  ISRCTN25573423

• Clinicaltrials.gov Identifier

  NCT04936620

• Duration of Study in the UK

  5 years, 11 months, 31 days

• Research summary

  DOES DUROPLASTY IMPROVE OUTCOME AFTER SPINAL CORD INJURY?
  WHAT DO WE STUDY? We will investigate whether performing a surgical procedure called duroplasty improves outcomes after spinal cord injury.
  WHY SPINAL CORD INJURY? Spinal cord injury is a devastating condition that causes permanent disability such as paralysis, numbness and loss of bladder and bowel control. Currently, there are no treatments shown to improve outcome after spinal cord injury.
  WHAT IS DUROPLASTY? Duroplasty is an operation that involves opening the tough membrane around the spinal cord, called the dura, and stitching a patch of artificial dura to expand the space around the swollen cord.
  WHY IS DUROPLASTY BEING STUDIED? Based on our preliminary evidence, we think that the tough membrane around the spinal cord (dura) causes cord pressure after injury. We have shown in a small study of patients that performing this operation safely and effectively reduces pressure on the injured cord.
  WHO IS ELIGIBLE? Adult patients with severe spinal cord injuries in the neck who will have surgery within 72 hours.
  WHAT TREATMENT? Those who agree to take part will be allocated by chance (like tossing a coin) to standard treatment or standard treatment plus duroplasty. Some patients will also be asked to take part in a smaller study that involves placing probes at the injury site.
  WHERE? We will recruit patients from U.K. Major Trauma Centres and, later on, from overseas.
  HOW LONG? We aim to recruit 222 – 260 patients over 4 years. Patients will be followed up for a year.
  WHAT DO WE ASSESS? Patients will be assessed (using questionnaires and by examination) how well they can use their hands, walk, control their bladder and bowel and their quality of life. Some of these assessments will be repeated at 3, 6 and 12 months after surgery.

• REC name

  London - Camberwell St Giles Research Ethics Committee

• REC reference

  21/LO/0216

• Date of REC Opinion

  24 May 2021

• REC opinion

  Further Information Favourable Opinion